FDA Approves Powerful New Opioid Despite Criticisms

FRIDAY, Nov. 2, 2018 (HealthDay News) — Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration today approved an extremely potent new opioid painkiller, Dsuvia.

The drug is a 30-mcg pill that packs the same punch as 5 mg of intravenous morphine, according to the Washington Post. The pill comes packaged in a syringe-like applicator and would be used under the tongue for quick absorption.

The drug is for very restricted use in operating rooms or on the battlefield. Indeed, its potential use by soldiers was one reason Dsuvia was approved, according to FDA Commissioner Scott Gottlieb, M.D. “The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain,” Gottlieb said in an agency news release.

An FDA advisory committee did recommend approval of Dsuvia in a 10-3 vote last month. But the committee’s chair took the highly unusual move of voicing his opposition at that time. Raeford Brown, M.D., a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug. But Gottlieb stressed today that his agency has placed very tight restrictions on Dsuvia. “To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use,” Gottlieb said. “It can’t be dispensed to patients for home use and should not be used for more than 72 hours. And it should only be administered by a health care provider using a single-dose applicator. That means it won’t be available at retail pharmacies for patients to take home.” The drug is also only intended for use by patients who cannot tolerate other painkillers or for whom other painkillers have failed or are expected to fail.

Washington Post Article
HealthDay Article
Statement From FDA Commissioner